Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

Pituitary Adenoma Clinical Trial

— POET  

Official title:

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014687
• Other study ID #: PHX-16-0134-30-12
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: July 2019

Study information

• Verified date: August 2018
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: Heidi Jahnke, RN, MSN
• Phone: 602-406-6976
• Email: heidi.jahnke[@]dignityhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages.

Description:

Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas. Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and pituitary gland, the technique causes disruption of sinonasal function and temporarily impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of postoperative morbidity following transsphenoidal surgery. Common sinonasal complications include sinusitis, synechiae formation, nasal obstruction and crusting. The development of postoperative sinusitis is specifically associated with decreased sinonasal function after surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard prophylactic perioperative intravenous antibiotics) with the intention of improving nasal functional outcomes. To date, no studies have examined whether the administration of oral antibiotics following transsphenoidal surgery improves sinonasal healing. This question has been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A meta-analysis of clinical trial data obtained in FESS indicated that current literature does not support the use of oral antibiotics to reduce infection, improve symptoms scores, or improve endoscopic findings. Furthermore, there is the potential for antibiotic-related adverse events including the emergence of bacterial resistance, Clostridium difficile infection, and allergic reactions to the medication. Despite the lack of supporting evidence in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma

• Adults >18 and <85 years of age

• English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales

• Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable

Exclusion Criteria:

• Anaphylaxis/intolerance to the study drugs

• Cirrhosis, hepatitis

• Any solid organ transplant or bone marrow transplant. And any patient felt to be immunocompromised by the investigators

• Renal failure on dialysis

• Any subject who is unwilling or unable to sign informed consent for the study

• Pregnancy

• Incarcerated patients

• Cushing's disease

• Rathke's Cleft cyst or pituitary cyst

• History of chronic sinusitis

• Anticipated use of nasal splints

• Anticipated use of nasal septal flap

• Active sinusitis

• Nasal polyps

• Previous sinus surgery

• Concurrent antibiotics for another indication (i.e., urinary tract infection)

• Immunodeficiency

Related Conditions & MeSH terms

• Adenoma
• Antibiotics
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• Placebo
PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
• Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
Oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Locations

Country	Name	City	State
United States	Barrow Brain and Spine	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	The Cleveland Clinic, Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)	Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Primary	Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22)	Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary	Incidence of Acute Bacterial Sinusitis	Incidence includes 3 or more of: i. Nasal congestion by patient report or physical exam, ii. Purulent nasal discharge by patient report or physical exam, iii. Facial pressure or pain or headache by patient report, iv. Antibiotics prescribed by a provider for the purpose of treating sinusitis.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary	Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)	Postoperative nasal endoscopy findings graded by surgeon. Grading includes Polyps = none 0; middle meatus 1; beyond middle meatus 2. Discharge = none 0; clear and thin 1; thick and purulent 2. Edema = none 0; mild 1; moderate 2; severe 3. Scarring = none 0; mild 1; moderate 2; severe 3. Crusting = none 0; mild 1; moderate 2; severe 3.	1-2 and 3-4 weeks post-surgery
Secondary	Sinusitis and antibiotic resistance as evidenced by nasal congestion	Cultures and sensitivities when nasal congestion noted by patient report or physical exam.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary	Sinusitis and antibiotic resistance as evidenced by purulent discharge	Cultures and sensitivities when purulent nasal discharge noted by patient report or physical exam.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary	Sinusitis and antibiotic resistance as evidenced by pressure	Cultures and sensitivities when facial pressure noted by patient report.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary	Sinusitis and antibiotic resistance as evidenced by pain	Cultures and sensitivities when facial pain noted by patient report.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary	Sinusitis and antibiotic resistance as evidenced headache	Cultures and sensitivities when headache noted by patient report.	1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery